Study of the Efficacy, Safety, and Pharmacokinetics of SM88 in Patients With Prostate Cancer

Phase 1/2 Completed 23 enrolled Tyme, Inc

NaSingle-groupOpen-labelTreatment

The purpose of this study is to evaluate the safety, pharmacokinetics, and efficacy of SM88 in patients with prostate cancer

Background Steve Hoffman, et al. An open-label trial of SMK treatment of advanced metastatic cancer. J Clin Oncol 31, 2013 (suppl; abstr e22095)
Background Steve Hoffman, et al. An Open-Label Trial of SMK Treatment of Advanced Metastatic Cancer. 18th World Congress on Controversies in Obstetrics, Gynecology & Infertility (COGI). 473-480, 2014 Monduzzi Editoriale | Proceedings.
Background Avi Retter. Non-Hormonal Therapy for Recurrent Non-Metastatic Prostate Cancer. Oncology Times. 40(4):29-31, February 20, 2018.
Background Del Priore G, Hoffman S. Timing of androgen-deprivation therapy in prostate cancer. Lancet Oncol. 2017 Nov;18(11):e633. doi: 10.1016/S1470-2045(17)30774-X. Epub 2017 Oct 31. No abstract available.
Gartrell BA, Roach M 3rd, Retter A, Sokol GH, Del Priore G, Scher HI. Phase II trial of SM-88, a cancer metabolism based therapy, in non-metastatic biochemical recurrent prostate cancer. Invest New Drugs. 2021 Apr;39(2):499-508. doi: 10.1007/s10637-020-00993-4. Epub 2020 Sep 13.

Evaluation	Drug	Modality	Dose	Route
Subject	L1-79	Unknown	230 mg	—
Subject	L1-79	Unknown	460 mg	—
Background	Methoxsalen	Other / unclassified	10 mg	—
Background	Phenytoin	Unknown	50 mg	—
Background	Sirolimus	Small molecule	0.5 mg	—